Global Program Regulatory Manager (GPRM), Oncology

RM IT Services GmbH

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Job ID :

16259


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

Global Program Regulatory Manager (GPRM)/ Early Development/ Oncology


Salary :

Negotiable


Date Posted :

11 May, 2021



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Pharma Business Development Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Global Program Regulatory Manager for a globally operating Basel based company in the pharmaceutical sector.
Your experience/skills:

* 2+ years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs- additional knowledge of other regions is an asset
* Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline
* Outstanding interpersonal, communication, negotiation, problem solving skills and ability to work in a global environment
* Advanced degree in a related scientific field with requisite demonstrated experience and capability
* Languages: English, fluent in written and spoken

Your tasks:

* Providing input into global regulatory strategy for early development compound
* Contributing to regulatory innovations, such as novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways
* Helping with identifying regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval
* Working in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures
* Participating in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs

Start: 06/2021
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH 16970
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health - and social insurance
* Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

For more information,visit www.rmgroup.ch.

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